Using glucocorticoids to prevent heart conduction issues after valve replacement
Glucocorticoid Treatment in Patients Undergoing TAVR to Reduce the Incidence of Atrioventricular Block and Pacemaker Implantation
This study is testing if a treatment with glucocorticoids can help prevent heart rhythm problems and the need for a pacemaker in patients who are having a valve replacement procedure.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Sex | All |
| Sponsor | Hospital General Universitario de Alicante Academic / other |
| Drugs / interventions | Prednisone |
| Locations | 1 site (Alicante) |
| Trial ID | NCT06076824 on ClinicalTrials.gov |
What this trial studies
This phase IV, randomized, controlled trial aims to evaluate the effectiveness of glucocorticoid treatment in preventing conduction abnormalities and the need for pacemaker implantation in patients undergoing transaortic valve replacement (TAVR). Participants will receive a single dose of intravenous Methylprednisolone followed by a short course of oral Prednisone, while a control group will receive a placebo. The study will assess the incidence of new conduction disturbances and pacemaker requirements at discharge, 30 days, and 1 year post-procedure. The trial will recruit 100 patients at the General University Hospital Dr. Balmis in Alicante, focusing on those with severe symptomatic aortic stenosis.
Who should consider this trial
Good fit: Ideal candidates are patients over 75 years old or those with high surgical risk who are eligible for TAVR due to severe symptomatic aortic stenosis.
Not a fit: Patients with a prior pacemaker, contraindications to glucocorticoids, or those on chronic glucocorticoid treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the incidence of conduction disturbances and the need for pacemaker implantation in TAVR patients.
How similar studies have performed: While the approach of using glucocorticoids in this context is novel, previous studies have suggested that inflammation management may reduce complications after similar procedures.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients eligible for TAVR implantation according to current European Society of Cardiology guidelines: patients with severe symptomatic aortic stenosis that are \> 75 years old or have a high surgical risk. Exclusion Criteria: * Patients with a prior pacemaker. * Patients with contraindications for the use of glucocorticoids including immunosuppression, active or latent infection, documented hypersensitivity or allergy, insulin-dependent diabetes mellitus, glaucoma (both closed-angle and open-angle), recent intestinal perforation, or acute heart failure. * Patients on prior chronic treatment with glucocorticoids (both oral, inhaled, or intravenous, but topical and ophthalmic administration is allowed). * Access for TAVR implantation other than femoral (for example, transapical). * Patients on medication that may interact with glucocorticoids.
Where this trial is running
Alicante
- General University Hospital of Alicante — Alicante, Spain (Recruiting)
Study contacts
- Study coordinator: Juan Miguel Ruiz Nodar
- Email: ruiz_jmi@gva.es
- Phone: 606998408
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.